COVID-19 Clinical Research Part 2: Clinical Researchers at the Tip of the Spear
by Robert Ryan
This week we continue our series on COVID-19 Clinical Research honoring the medical researchers working on the frontlines of the Pandemic in search of effective treatments and a vaccine. Like the volunteers raising their hand to participate in COVID research, clinical researchers and medical scientists with their collective purpose and effort are heroes of the COVID-19 era. They serve at the heart of the struggle that defines a historic time, in which the urgency of a breakthrough has never been greater.
With American fatalities this week surpassing 80,000, and climbing higher each day, we look for signs of progress abroad as lockdown measures are gradually lifted, but are mostly disappointed by news of resurgence. We are in a protracted struggle, and battling an opponent most of us can’t see. But, medical researchers can see it, and they form the tip of the spear as we march forward.
In April, the tip of the spear got very sharp, very fast. Clinical researchers at the nation’s top academic medical centers commenced a rapid mobilization. At the University of Pennsylvania it took just 24 hours to initiate major reorganization to concentrate efforts on COVID-19 research and clinical care. By the start of April Penn had 5 COVID-19 clinical trials and 3 research studies enrolling volunteers, including a DNA vaccine trial, and treatment trials testing the efficacy of Remdesivir on COVID-19 patients. It happened in less than 2 weeks; ask any research professional and they will tell you this is a monumental achievement. Clinical researchers normally face a lengthy process before they can actually start doing research with patient volunteers. It can take a year to secure funding, 3 months for administrative and regulatory document reviews and approvals, then weeks or months to recruit volunteers.
How did they manage this herculean feat? To start, it mattered greatly to have the full institutional support of a premiere academic medical center like Penn. Philanthropic donations eliminated any financing delays. The dedication of the research teams, executive leaders and administrators was also a factor. Everyone worked around the clock to get the trials and studies up and running quickly. And, a spirit of volunteership and common purpose emerged among Penn research professionals and became a force multiplier. Such support and expertise has boosted both the scientific mission and accelerated trial enrollment as many research professionals have assisted with patient screening and processing.
When it came time to find volunteers, technology played a significant part in the successful outreach and enrollment. iConnect, the TrialX Patient Recruitment Management System gave the researchers an online platform to connect with the public remotely, pre-screen for eligibility and track progress toward target accrual. At the time of writing, iConnect processed nearly 1400 volunteers for COVID-19 research at Penn alone. It facilitated remote recruitment, an important capability under social distancing conditions, and as a result Penn’s vaccine trial met its target enrollment.
What is going on at the tip of the spear is something we can all rally behind in this difficult time. And the spear is not only sharp at UPenn in Philadelphia, but in Indiana, in Boston, in New York, and across the U.S. where top academic medical centers have also mobilized to fight COVID-19. According to the website covidclinicaltrials.com 858 Principal Investigators and their teams have launched 558 clinical trials and research studies. It is a mobilization of immense proportions and without precedent in modern medicine. And, it is how we will win the fight against COVID-19.